ClinicalTrials.gov record NCT05882175

Prospective Validation of the OHI Index

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Prospective Study to Validate the Prognostic Power of the Optimized HLH Inflammatory (OHI) Index

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationIsrael
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational cohort study of adults with new or transformed hematologic malignancies to evaluate the OHI index. It will compare one-year survival between patients who are OHI+ and OHI- and report the incidence of OHI+ over three years. OHI is defined by combined elevations of sCD25 (>3,900 U/mL) and ferritin (>1,000 ng/mL).

What it is studying. Whether the Optimized HLH Inflammatory (OHI) index—defined as sCD25 >3,900 U/mL plus ferritin >1,000 ng/mL—has prognostic value in people with hematologic malignancies, and how common OHI+ is in an unselected cohort.

What the researchers hope to learn. To validate the prognostic power of the OHI index by comparing 365-day mortality between OHI+ and OHI- patients, and to determine the incidence of OHI+ within the enrolled cohort.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) > 3,900 U/mL and ferritin >1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients with hematologic malignancies
  • At least 18 years old

Exclusion criteria

  • Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The investigators will enroll patients with new/transformed hematologic malignancies. The investigators will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would have blood tests to measure sCD25 and ferritin so investigators can assign OHI+ or OHI- status. Investigators will follow your health and survival until the study ends and report one-year mortality and the cohort incidence of OHI+ (incidence assessed after three years of enrollment). The record does not list other specific procedures or invasive tests.

How the study is structured. A prospective observational cohort study. Adults with new or transformed hematologic malignancies are enrolled and classified as OHI+ or OHI- based on blood tests (sCD25 and ferritin). No treatment is assigned by the study; participants are followed over time and one-year survival is compared between groups (Kaplan–Meier). Incidence of OHI+ will be calculated after three years of enrollment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Israel. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hemophagocytic lymphohistiocytosis

Clinical trials34 trials listed for hemophagocytic lymphohistiocytosisEvery trial the registry lists for hemophagocytic lymphohistiocytosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hemophagocytic lymphohistiocytosis researchLatest monthly update: September 2026. Includes: Multiple test results. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 3, 2021
Primary completion
Mar 3, 2030 (estimated)
Study completion
Mar 3, 2030 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
May 13, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Meir Medical Center
Collaborators
  • Children's Hospital Medical Center, Cincinnati
  • Rabin Medical Center
  • Sheba Medical Center
  • Schneider Children's Medical Center, Israel

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

overall survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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